Sarepta initiated an additional Phase 3 trial for Elevidys as it attempts to win European marketing authorization after EMA denied approval last year. The European Medicines Agency cited insufficient evidence of efficacy and safety, including an observed lack of significant movement benefit at 12 months in the earlier evidence package. Roche, which licensed Elevidys, will oversee the new registration-enabling study. Reporting says the follow-up trial will generate additional placebo-controlled efficacy and safety data over 72 weeks to address EMA’s concerns. The timeline remains challenging for patients and companies: primary data is expected in a few years, while the program follows prior safety scrutiny in the U.S. after deaths reported in non-ambulatory patients and subsequent shipping and dosing suspensions.